Intelligent medical device barrier

ABSTRACT

The present invention relates to an intelligent medical device barrier in which a barrier includes sensory means in order to determine if the cover is in place properly and insure single use of the barrier. The sensory means allows one set of readings to be taken using the medical device. The sensory means can provide a lot number, serial number or calibration data to the medical device. After use of the medical device barrier, the sensory means prevents re-use of the barrier for a subsequent procedure.

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional PatentApplication No. 60/425,784, filed Nov. 12, 2002, the entirety of whichis hereby incorporated by reference into this application.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to an intelligent medical devicebarrier to sense when a barrier is properly attached to a medical devicethereby insuring proper use and single use of the barrier.

[0004] 2. Description of Related Art

[0005] Various medical devices are used in medical procedures. If themedical device can be re-used, it is desirable to assure cleanliness ofthe device. Conventional methods for sterilizing medical devices includeheating, washing and covering of the medical device during use.

[0006] U.S. Pat. No. 6,142,959 describes using a thin elastic protectivefilm to cover a probe head and shaft during use. The thin elastic coveris held by a fixing ring to the handle. The thin elastic cover can beremoved from the probe and discarded. Thereafter, a new thin elasticcover can be placed over the shaft before the next use for providingimproved hygienics of the prostate examination.

[0007] U.S. Pat. No. 6,582,368 describes a medical instrument sheathformed of a body of a nonconductive material. A piezoelectric copolymertransducer is held snugly against the medical device by the sheath body.The sheath body may be constructed of a shrink tube such aspolytetrafluorethylene which shrinks when exposed to heat. After use,the sheath is removed from the medical device and discarded. The medicaldevice may then be used either in conjunction with another sheath oralone. The sheath may also be used in conjunction with a disposablemedical device, where both the sheath and the device are disposed of atthe end of the procedure. No prior art of which applicant is aware,provides a mechanism for insuring that the elastic cover has been usedfor a single procedure.

[0008] It is desirable to provide a medical device barrier tocommunicate with a medical device and to assure single use of thebarrier.

SUMMARY OF THE INVENTION

[0009] The present invention relates to an intelligent medical devicebarrier in which a barrier includes sensory means to determine if thecover is in place properly and insure single use of the barrier. Thesensory means allows one set of readings to be taken using the medicaldevice. The sensory means can provide a lot number, serial number orcalibration data to the medical device. After use of the medical devicebarrier, the sensory means prevents re-use of the barrier for asubsequent procedure. The medical device barrier covers all surfaces ofthe medical device which contact tissue to prevent viral or bacterialtransmission. For example, in a probe device the barrier covers theprobe shaft and probe sensor area in order to prevent probe contact withpatient tissue. The invention will be more fully described by referenceto the following drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1A is a perspective diagram of an intelligent medical devicebarrier attached to a probe in accordance with the teachings of thepresent invention.

[0011]FIG. 1B is a cross sectional view of the intelligent medicaldevice barrier and probe shown in FIG. 1A.

[0012]FIG. 2A is a perspective view of an alternative intelligentmedical device barrier.

[0013]FIG. 2B is a cross sectional view along line A-A of FIG. 2A.

[0014]FIG. 2C is a cross sectional view along line B-B of FIG. 2A.

[0015]FIG. 2D is a cross sectional view along line C-C of FIG. 2A.

[0016]FIG. 3A is a perspective view of an alternate embodiment of anintelligent medical device barrier attached to a probe.

[0017]FIG. 3B is a top plan view of a probe handle used with theintelligent medical device barrier shown in FIG. 3A.

[0018]FIG. 3C is a side elevational view of the probe handle shown inFIG. 3B.

[0019] FIG. 3D is a cross sectional view of the probe handle receivingthe medical device barrier.

[0020]FIG. 3E is a bottom plan view of the probe handle shown in FIG.3B.

DETAILED DESCRIPTION

[0021] Reference will now be made in greater detail to a preferredembodiment of the invention, an example of which is illustrated in theaccompanying drawings. Wherever possible, the same reference numeralswill be used throughout the drawings and the description to refer to thesame or like parts.

[0022]FIGS. 1A and 1B are schematic diagrams of an embodiment of anintelligent medical device barrier 10 in accordance with the teaching ofthe present invention. Cover 12 is formed of a similar shape of probehead 13 and probe handle 14 of probe 11. Cover 12 is received over tip 8and probe head 13 and is pulled or rolled up over shaft 9 of probe head13 in order to be used as a barrier to probe 11. Cover 12 can bereceived over portion 7 of probe handle 14 for insuring shaft 9 iscompletely covered by cover 12. For example, probe 11 can be a probeused for examination of the prostate as described in U.S. Pat. No.6,142,959, hereby incorporated by reference into this application.

[0023] Retaining means 15 secures cover 12 in place on probe handle 14.For example, retaining means 15 can be a detent, tab, snap catch, hookor ring for coupling cover 12 to probe handle 14 which inserts, snaps ortwists into place on probe handle 14. Retaining means 15 providesexpeditious attachment of cover 12 to probe head 13. For example, cover12 can be installed or removed on probe head 13 and probe handle 14 inless than about 10 seconds. Retaining means 15 can be coupled to cover12. Alternatively, retaining means 15, such as a ring, can be placedover cover 12 to press cover 12 against probe handle 14.

[0024] One or more sensors 16 can be attached to one or morepredetermined positions on handle 14, retaining means 15 or cover 12 forsensing when cover 12 is in place properly on probe head 13. In oneembodiment illustrated in FIG. 2A, sensor 16 is coupled to retainingmeans 15 and retaining means 15 is attached to cover 12. Retaining means15, such as a detent, is coupled to an indentation or protrusion inprobe handle 14. Upon probe handle 14 engaging retaining means 15,sensor 16 is activated to indicate that cover 12 is in place on probehandle 14. If it is determined cover 12 is in place properly on probehead 13, probe 11 can be activated to enable its use for examination.

[0025] Sensor 16 provides data, such as an identification. Theidentification can include a lot number or serial number for cover 12.Alternatively, the identification can be a different state of sensor 16,such as a different color if cover 12 had been previously used. Datafrom sensor 16 is forwarded to electronic unit 20 over link 19.Electronic unit 20 determines from the identification if cover 12 hadbeen previously used. If it is determined cover 12 has not beenpreviously used, electronic unit 20 can be adapted to activate probe 11to enable its use for examination. If it is determined cover 12 has beenpreviously used, electronic unit 20 can deactivate probe 11 to preventits use for examination.

[0026] Sensor 16 can also provide an expiration date such as amanufacture date plus a shelf life over link 19. If it is determinedcover 12 is expired, electronic unit 20 can deactivate probe 11 toprevent its use in examination. Sensor 16 can also provide calibrationdata to probe 11 for operation of probe head 13.

[0027] One or more sensors 17 receive information upon use of probe 11.Sensor 17 can be coupled to any position of cover 12. Alternatively,sensor 17 can be coupled to retaining means 15 or probe handle 14.Sensor 17 can link through probe handle 14 to electronic unit 20 overlink 19. Data acquisition of probe 11 from sensor 17 can be forwardedover link 19 to electronic unit 20.

[0028] Sensor 16 can be an integrated circuit. Electronic unit 20 caninclude a processor, display device, storage unit and central unit. Inone embodiment, electronic unit 20 can be a personal computer.Alternatively, electronic unit 20 can be housed in probe handle 14. Inthis embodiment, electronic unit 20 comprises a processor and storageunit. Data stored in electronic unit 20 of probe handle 14 can be lateruploaded to a remote computing device, such as a personal computer.

[0029] Examples of sensor 17 include restive pad sensors such asmanufactured by Tekscan or Vistamed, force sensitive register pads, suchas manufactured by PPS, strain gages or MEMS pressure die. For example,link 19 can be a wireless link, optical link or direct electricalconnection. Electronic coding of sensor 16 and sensor 17 can beperformed by radio frequency (RFID) tag, RFID direct connect, EEPROM,electrical fuse, ink and barcode. For example, in the use of a RFID-tagor RFID direct connect a read/write integrated circuit is used in sensor16 and/or sensor 17 in probe handle 14. In RFID-tag, sensor 16 or sensor17 communicates over a wireless link to probe handle 14. In RFID-tagdirect connect, sensor 16 or sensor 17 communicates over a direct linkto probe handle 14. In EEPROM, a plurality of electrical contacts areused to communicate between sensor 16 or sensor 17 to probe handle 14 toprovide an erasable data, such as an identification number or serialnumber. Alternatively, for example, four electrical contacts can be usedin EEPROM. In electrical fuse, electrical contacts are used tocommunicate between cover 12 and probe handle 14. For example, twoelectrical contacts can be used to form an electrical fuse. For example,in the use of ink, the ink can disappear from transparent to opaque uponexposure to heat, temperature or UV. An optical interrupter can be usedto detect the change in the ink state. Accordingly, upon use of probe11, probe handle 14 can transmit a wavelength of a predeterminedintensity for changing the ink state of sensor 16 or sensor 17. In thecase of a barcode, the barcode of sensor 16 or sensor 17 is written oncover 12 or on a label on cover 12. Electronic unit 20 can include abarcode reader for reading the barcode or the barcode reader can belocated on probe 11.

[0030] Cover 12 can be formed to have a shape similar to the medicaldevice to provide a barrier to protect the medical device. For example,as shown in FIG. 2A, cover 12 can have various cross sectional shapesalong lines A-A of FIG. 2B, B-B of FIG. 2C and C-C of FIG. 2D whichcorrespond to the shape of probe 11 and allow pivoting of probe head 13.

[0031] Coupling means 21 can be used to retain cover 12 on probe 11 inaddition to retaining means 15. For example, coupling means 21 can be ahook.

[0032] In one embodiment, cover 12 can include pull-tab 22 which ispulled to remove cover 12 from probe 11. Pull-tab 22 is attached toreduced thickness portion 24 of cover 12. Reduced thickness portion 24of cover 12 can tear when pull-tab 22 is pulled. Accordingly, afterpull-tab 22 tears reduced thickness portion 24, probe 11 is unable to bere-used in a subsequent procedure and insures single use of cover 12.

[0033]FIGS. 3A-3E illustrate an alternate embodiment of an intelligentmedical barrier device 30 in accordance with the teachings of thepresent invention. Cover 29 is coupled to collar 30 at bonding portion31 of cover 29, as shown in FIG. 3A.

[0034] Enable switch 32 is formed on portion 33 of probe handle 14, asshown in FIG. 3B and FIG. 3C. For example, portion 33 can have acircular or elliptical shape for receiving collar 30. Collar 30 can havea circular shape that can be transformed into an elliptical shape uponreceipt over an elliptical probe handle 14 or can have a circular shapeto be received over a circular probe handle 14.

[0035] Enable switch 32 includes upper portion 34 and contact 35, asshown in FIG. 3D. Collar 30 includes protrusion 36 formed on innersurface 37 of end 38 of collar 30. Collar 30 has detail 40 formed oninner surface 37 of end 38 of collar 30. Probe handle 14 includes ledge42 on portion 33 of probe handle 14. During operation, collar 30 slidesover portion 33 of probe handle 14 until protrusion 36 contacts upperportion 34 of enable switch 32 and detail 40 fits into ledge 42 forsnapping collar 30 in place on probe handle 14. Upon contact ofprotrusion 36 with upper portion 34 of enable switch 32, contact 35 iscontacted to activate enable switch 32. Activation of enable switch 32indicates cover 29 is in place properly on probe 11. Thereafter, contactwith ledge 42 can release collar 30 for detaching cover 29 from probehandle 14, as shown in FIG. 3E.

[0036] Barcode label 44 can be attached to collar 30. Electronic unit 20can include a barcode reader for reading the barcode 44 or the barcodereader can be located on probe 11. Alternatively, sensor 16 and/orsensor 17 can be attached to collar 30.

[0037] Cover 12 and cover 29 can be formed of a biocompatible barriermaterial. Suitable materials for cover 12 include polyurethane,terphalate polyethylene and silicone. Cover 12 and cover 29 can have awall thickness in the range of about 0.0001 to about 0.015 inches. It isdesirable that cover 12 is designed to prevent damage of sensor 16 orsensor 17. Cover 12 and cover 29 can be sterilized. Cover 12 and cover29 can be packaged in a sealed sterilized pouch.

[0038] Collar 30 can be formed of a hard plastic material. Cover 12,cover 29 and collar 30 can be formed by dip molding, one or two shotinjection molding, or liquid injection molding.

[0039] In alternate embodiments, cover 12 or cover 29 can have a shapeto be compatible with any medical device, such as for example, acatheter, endoscope or ultrasound device. Sensor 16, sensor 17 or enableswitch 32 can be designed to interact with the desired medical device.

[0040] In an alternate embodiment, data on the number of uses ofdifferent covers 12 or covers 29 with probe 11 is collected byelectronic unit 20. Probe 11 is activated for a predetermined one ormore number of times based on the collected data.

[0041] It is to be understood that the above-described embodiments areillustrative of only a few of the many possible specific embodimentswhich can represent applications of the principles of the invention.Numerous and varied other arrangements can be readily devised inaccordance with these principles by those skilled in the art withoutdeparting from the spirit and scope of the invention.

What is claimed is:
 1. An intelligent medical device barrier comprising:a cover adapted to be received over a medical device; and sensor meansfor sensing if said cover has been received on said medical device andis in place properly on said medical device, wherein said medical deviceis adapted to be activated after a determination that said cover is inplace properly on said medical device.
 2. The intelligent medical devicebarrier of claim 1 wherein said sensor means provides an identificationfor said cover and said sensor means is coupled to said cover furthercomprising: said intelligence means receiving said identification fromsaid sensor means and determining from said identification if said coverhas not been previously used; and activating means for activating saidmedical device, said activating means being coupled to said medicaldevice, said activation means is adapted to activate said medical deviceif it is determined said cover has not been previously used.
 3. Theintelligent medical device barrier of claim 1 further comprising aretaining means for securing said cover to said medical device.
 4. Theintelligent medical device barrier of claim 3 wherein said retainingmeans is coupled to said cover and said sensing means is coupled by saidretaining means to said cover.
 5. The intelligent medical device barrierof claim 3 wherein upon said retaining means being secured to saidmedical device said sensor means is activated.
 6. The intelligentmedical device barrier of claim 3 wherein said retaining means is adetent, tab, snap catch, hook or ring.
 7. The intelligent medical devicebarrier of claim 3 wherein said retaining means is a detent which iscoupled to an indentation or protrusion on said medical device.
 8. Theintelligent medical device barrier of claim 3 wherein said retainingmeans inserts, snaps or twists into place on said medical device.
 9. Theintelligent medical device barrier of claim 2 wherein saididentification is selected from the group consisting of a lot number,serial number and color.
 10. The intelligent medical device barrier ofclaim 1 wherein said sensor means provides an expiration date for saidcover and further comprising intelligence means coupled to said sensingmeans, said intelligence means receiving said expiration date from saidsensor means and determining from said expiration date if said cover hasnot expired; and activation means coupled to said medical device adaptedto activate said medical device, said activation means activating saidmedical device if it is determined said cover has not expired.
 11. Theintelligent medical device barrier of claim 2 wherein said sensor meansfurther includes calibration data which is forwarded to saidintelligence means.
 12. The intelligent medical device barrier of claim2 further comprising second sensor means for receiving information uponuse of said medical device.
 13. The intelligent medical device barrierof claim 2 wherein said intelligence means comprises an electronic unitand said identification is forwarded over a link to said election unit.14. The intelligent medical device barrier of claim 13 wherein said linkis selected from the group consisting of: a wireless link, optical linkand electrical connection.
 15. The intelligent medical device barrier ofclaim 2 wherein said sensing means provides said identification by radiofrequency (RFID) tag, RFID direct connect, EEPROM, electrical fuse, inkor barcode.
 16. The intelligent medical device barrier of claim 2wherein said identification is in the form of an ink, a state of saidink being changed upon exposure to heat, temperature or wavelength of apredetermined intensity and said intelligence means includes an opticalinterrupter to detect said state of said ink.
 17. The intelligentmedical device barrier of claim 2 wherein said identification is in theform of a barcode and said intelligence means includes a barcode readerfor reading said barcode.
 18. The intelligent medical device barrier ofclaim 1 wherein said cover includes a pull tab attached to a reducedthickness portion of said cover, said pull tab being torn wherein saidpull tab is used to remove said cover from said medical device, whereinsaid cover is unable to be re-used.
 19. The intelligent medical devicebarrier of claim 1 wherein said sensor means comprises an enable switchcoupled to said medical device and said cover includes a collar, saidcollar contacting said enable switch when said collar is in place. 20.The intelligent medical device barrier of claim 19 wherein said collarincludes a detail and said medical device includes a ledge, said detailfits into said ledge for snapping said collar in place on said medicaldevice.
 21. The intelligent medical device barrier of claim 20 whereinsaid collar further comprises a protrusion for contacting said enableswitch.
 22. The intelligent medical device barrier of claim 1 whereinsaid collar is formed of a hard plastic material.
 23. The intelligentmedical device barrier of claim 1 wherein said cover is formed of amaterial selected from the group consisting of: polyurethane, terphalatepolyethylene and silicone.
 24. The intelligent medical device barrier ofclaim 1 wherein said medical device is a probe.
 25. A method for using amedical device comprising the steps of: installing a cover over saidmedical device sensing if said cover has been received on said medicaldevice and is in place properly on said medical device; and activatingsaid medical device after a determination that said cover is in placeproperly on said medical device.
 26. The method of claim 25 before saidactivating step further comprising the steps of: determining if saidcover has not been previously used and deactivating said medical deiceif it is determined said cover has not been previously used.
 27. Themethod of claim 22 wherein said determining step includes providing anidentification in said sensing step from a sensor to an intelligencemeans and determining from said identification if said cover has notbeen previously used.
 28. The method of claim 27 wherein saididentification is selected from the group consisting of a lot number,serial number and color.
 29. A method for using a medical devicecomprising the steps of: installing a cover over said medical devicedetermining if said cover has not been previously used; and activatingsaid medical device if said cover has not been previously used.
 30. Themethod of claim 29 wherein said determining step includes providing anidentification in said sensing step from a sensor to an intelligencemeans and determining from said identification if said cover has notbeen previously used.